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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02119065
Other study ID # OSU-13176
Secondary ID NCI-2014-00278
Status Active, not recruiting
Phase
First received
Last updated
Start date January 30, 2014
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot clinical trial studies positron emission tomography (PET)/computed tomography (CT) in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are present in the lung and compare the results with the pre-therapy imaging.


Description:

PRIMARY OBJECTIVES: I. To estimate the absolute difference in post-therapy Yttrium-90 microsphere hepatopulmonary shunt fraction and the pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction in patients with unresectable primary hepatic malignancy and hepatic metastatic disease. SECONDARY OBJECTIVES: I. To quantify and compare the pre-therapy Technetium-99m macroaggregated albumin particle sizes and post-therapy Yttrium-90 microsphere sizes. OUTLINE: Patients receive routine pre-therapy Technetium-99m macroaggregated albumin. Patients then undergo routine radioembolization with Yttrium-90 microspheres. Within 36 hours after radioembolization, patients undergo PET/CT imaging. Available imaging, clinical, interventional and surgical follow-up data for 2 years after completion of enrollment in the study will be obtained.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6
Est. completion date December 31, 2024
Est. primary completion date July 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who undergo intra-arterial hepatic 99mTc MAA evaluation in anticipation of 90Y microsphere radioembolization Exclusion Criteria: - Patients who are unable to give consent - Prisoners

Study Design


Related Conditions & MeSH terms

  • Advanced Adult Primary Liver Cancer
  • Liver Metastases
  • Liver Neoplasms
  • Localized Unresectable Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer

Intervention

Procedure:
positron emission tomography
Undergo PET/CT scan
computed tomography
Undergo PET/CT scan

Locations

Country Name City State
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absolute difference in post-therapy Yttrium-90 microsphere and pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction values Non-parametric Wilcoxon signed rank testing will be used to compare the 99mTc MAA and 90Y microsphere shunt fractions. Alternatively, a natural log transformation of the hepatopulmonary shunt fractions may be used to normalize these data for subsequent parametric paired t-test analysis. Baseline to up to 36 hours after radioembolization
Secondary In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient Descriptive statistical assessment of Technetium-99m macroaggregated albumin particle size and microsphere size for each patient (e.g., mean, median, standard deviation, distribution, etc.) will be performed. Baseline up to 24 months
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